User's Manual

Absolute Differences in Peak VO
2
and QOL
The tables below show the absolute differences between the control and test groups’ peak
VO
2
and QOL over the 6 month follow-up period in the clinical trial.
Absolute difference between test and control groups’ change in peak V0
2
over 6
months
Baseline
Mean ± SD
(range)
6-month
Mean ± SD
(range)
Difference
within
group
Difference
between
groups
Control
group
(n=41)
13.39 ± 4.58
(5.02, 24.10)
13.12 ± 3.99
(3.30, 20.70)
- 0.28 1.85Change in Peak
VO2
(mL/min/Kg)
Test
group
(n=91)
11.84 ± 3.90
(3.50, 26.3)
13.41 ± 4.28
(6.18, 27.67)
1.57
Absolute difference between test and control groups’ change in QOL score over
6 months
Baseline
Mean ± SD
(range)
6-month
Mean ± SD
(range)
Difference
within
group
Difference be-
tween groups
Control
group
(n=41)
47.5 ± 19.29
(9, 90.3)
31.21 ± 23.96
(0, 95)
16.29 1.28Change
in QOL
Test
group
(n=91)
52.81 ± 21.84
(9, 92)
35.24 ± 23.73
(0, 93)
17.57
The table below presents the percentage of patients in each group who improved, worsened,
or remained unchanged in each element of the composite score and the composite score
itself.
QOL score VO
2
Score Composite Score
Control
GROUP
Test
GROUP
Control
GROUP
Test
GROUP
Control
GROUP
Test
GROUP
% Im-
proved
75.6 74.7 48.8 67.0 62.2 70.9
% Wors-
ened
24.4 25.3 51.2 31.9 37.8 28.6
% Un-
changed
0.0 0.0 0.0 1.1 0.0 0.0
Histograms for Respiratory Exchange Rate (RER) at peak VO
2
at baseline and 6 month
follow-up are provided below:
6.1.4.
6. CLINICAL STUDIES
SORIN – PLATINIUM 4LV CRT-D 1744 – U904A 19